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Influence of Periodontal Treatment During Pregnancy in Adverse Pregnant Outcomes

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00893802
First received: May 4, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted

May 4, 2009
May 4, 2009
August 2001
August 2002   (final data collection date for primary outcome measure)
Primary outcome measures recorded are: preterm birth (PTB), defined as delivery < 37 weeks; low birth weight (LBW), defined as < 2.500Kg birth weight; preterm birth and low birth weight [ Time Frame: Within 30 days after delivery ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Secondary outcome measures are: late abortion (14-24 gestational weeks); and abortion (< 14 gestational weeks) [ Time Frame: Within 30 days after development ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Influence of Periodontal Treatment During Pregnancy in Adverse Pregnant Outcomes
Influence of Periodontal Treatment in Pregnant Women Attending Antenatal Care at a Public Health Center in Adverse Pregnant Outcomes: a Controlled Clinical Trial

The aim of this study is to evaluate the effects of treatment of periodontal disease during the second trimester of gestation in adverse pregnancy outcomes.

Pregnant patients during the 1st and 2nd trimesters at antenatal care in a Public Health Center will be divided into two groups: NIG- 'no intervention' or IG- 'intervention,' according to agreement in receive periodontal treatment during pregnancy. Treatment will be performed by a single periodontist consisting of scaling and root planning (SRP), professional prophylaxis (PROPH) and oral hygiene instruction (OHI). Patients at NIG will receive PROPH and OHI during pregnancy and will be referred for treatment after delivery. Periodontal evaluation will be performed by a single trained examiner, blinded to periodontal treatment, according to probing depth (PD), clinical attachment level (CAL), plaque index (PI) and sulcular bleeding index (SBI) at baseline and 35 gestational weeks-28 days post-partum. Primary adverse pregnancy outcomes to be addressed are: preterm birth (< 37 weeks), low birth weight (< 2.500 Kg), late abortion (14-24 weeks) or abortion (< 14 weeks). The results obtained will be statistically evaluated according to OR, unpaired t test and paired t test.

It is expected that periodontal treatment during the second trimester of gestation will result in decreased rates of adverse pregnancy outcomes.

All patients entering the study at the 1st and 2nd trimesters will be invited to participate in an oral health program, including oral hygiene instruction, caries diagnosis and treatment, and evaluation and treatment of periodontal conditions during the second trimester. Those who refuse to receive periodontal treatment during pregnancy will constitute the 'no intervention' control group (NIG), while those who agree in receiving dental and periodontal treatment during the second trimester of gestation will constitute the 'intervention' group (IG).

Patients are going to be evaluated by a single calibrated periodontist blinded in relation to periodontal treatment, which will be performed by another periodontist. Treatment consists of scaling and root planning, professional prophylaxis and oral hygiene instruction. Obstetrical data, birth weight and gestation duration will be recorded after examination and recording by the responsible obstetrician and nursery staff.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Periodontal Disease
Other: Scaling and root planning
Intervention will consist of supra and subgingival scaling and root planning performed by a single trained periodontist using Gracey curettes (Hu-Friedy, Chicago, USA) without local or general anesthesia during the second trimester of gestation, followed by professional prophylaxis and oral hygiene instruction. Treatment will be performed only once during study.
  • Experimental: Periodontal treatment
    Scaling and root planning
    Intervention: Other: Scaling and root planning
  • No Intervention: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
September 2002
August 2002   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • confirmed singleton gestations
  • pregnancy of 9-24
  • systemically healthy women
  • age range: 16-39 years old

Exclusion Criteria:

  • non confirmed pregnancy
  • age inferior to 16 years or superior to 39 years
  • multiple gestations
  • smoking
  • alcohol or drugs abuse
  • history of congenital heart disease
  • current use of corticosteroids or antibiotics
  • presence of systemic conditions (eg: diabetes, hypertension, or genitor-urinary infections)
Female
16 Years to 39 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00893802
CEP102/2002/FOB, CEP 102/2002
No
Adriana Campos Passanezi Sant'Ana, Discipline of Periodontics, School of Dentistry at Bauru-USP
University of Sao Paulo
Not Provided
Study Director: Adriana P Sant'Ana, DDS PhD Associate Professor - School of Dentistry at Bauru-USP
Principal Investigator: Marinele R Campos, DDS Graduation student on Periodontics (Master level). School of Dentistry at Bauru - USP
University of Sao Paulo
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP